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Details for Generic Name: regadenoson

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Regadenoson is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-seven patent family members in twenty-four countries.

There are three drug master file entries for regadenoson. One supplier is listed for this compound.

Summary for Generic Name: regadenoson

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packaging: see list1

Pharmacology for Ingredient: regadenoson

Clinical Trials for: regadenoson

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes8,106,029<disabled><disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes7,655,637<disabled>YY<disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes6,642,210<disabled>YY<disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes8,470,801<disabled><disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes7,144,872<disabled>YY<disabled>
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Non-Orange Book Patents for Generic Ingredient: regadenoson

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,268,988Process for preparing an A2A-adenosine receptor agonist and its polymorphs<disabled in preview>
8,278,435N-pyrazole A2A receptor agonists<disabled in preview>
8,071,566Methods of coronary imaging<disabled in preview>
7,956,179Process for preparing an A2A-adenosine receptor agonist and its polymorphs<disabled in preview>
7,671,192Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs<disabled in preview>
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International Patent Family for Ingredient: regadenoson

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2007092372Aug 16, 2007
Norway20016350Dec 21, 2001
China101076343Nov 21, 2007
Norway2011002Oct 22, 2012
Norway20083395Aug 27, 2008
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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